Regeneron, Sanofi to Test Arthritis Drug as Coronavirus Treatment

Drugmakers Regeneron Pharmaceuticals Inc. and Sanofi SA are racing to launch clinical trials exploring whether their arthritis drug could treat symptoms of novel coronavirus infections.
The study preparations mark the latest effort in an emerging front in researchers’ hunt for effective treatments for Covid-19, the respiratory disease caused by the novel coronavirus. In the U.S., there aren’t any drugs or vaccines approved for the condition.
The research aims to see whether certain drugs already on the market to tackle immune disorders like rheumatoid arthritis could help ease damage to the lungs and respiratory system caused by the immune system’s overreaction to the virus causing Covid-19. The drugs wouldn’t treat the underlying virus.
The research aims to see whether certain drugs already on the market to tackle immune disorders like rheumatoid arthritis could help ease damage to the lungs and respiratory system caused by the immune system’s overreaction to the Covid-19 virus, rather than killing it.
The Sanofi and Regeneron drug, called Kevzara, was approved by the Food and Drug Administration in 2017 to treat rheumatoid arthritis.
“The goal would be in the next couple of weeks to have the trial up and running, and in weeks to months after that to have the data,” Regeneron Chief Scientific Officer George Yancopoulos said in an interview on Tuesday.
Boosting the rationale for studying Kevzara’s effect on Covid-19 was a recent report by Chinese researchers that a similar-acting drug, Actemra from Roche Holding AG, had helped a small group of patients with severe or critical Covid-19 disease recover.
Several patients in the study “got out of death’s bed and walked out of the hospital” after receiving Actemra, Dr. Yancopoulos said. However, he cautioned that the study required repeating because it was small, not controlled and didn’t have defined parameters for success.
Genentech, a Roche subsidiary, said it is exploring opportunities to conduct U.S. studies of Actemra in Covid-19 patients with pneumonia, said a company spokeswoman. A study of the drug on Covid-19 was recently begun by the First People’s Hospital of University of Science and Technology of China, she said.
Both Actemra and Kevzara block proteins called interleukin-6, or IL-6, that trigger the body’s immune and inflammatory response. Normally the response helps fight infections. If the immune system overreacts, however, it can attack healthy tissue and organs.
In some novel coronavirus patients, the immune response may be accelerating and damaging the lungs even after significantly diminishing the amount of virus in the body, said Naimish Patel, Sanofi’s head of global development for immunology and inflammation, in an interview.
Blocking IL-6 may put the brakes on the immune system and keep the body from attacking itself, he said.
“Even though the virus is diminishing, it’s sending signals to the immune system to keep attacking,” said Dr. Patel. “If there’s too much inflammation, you end up killing cells that aren’t infected and leading to more damage than you really need.”
Symptoms associated with Covid-19 include fever, low oxygen levels in the blood and difficulty breathing.
One concern about deploying drugs that dampen the immune system is that patients could become more prone to infection, said Timothy Sheahan, assistant professor of epidemiology at the University of North Carolina, who conducts laboratory research into drugs for coronaviruses, including Gilead Sciences Inc.’s remdesivir.
Several drugmakers in addition to Gilead are looking for drugs aiming to cure novel coronavirus infections, while Sanofi and other companies are working on vaccines to prevent the infections.
Regeneron is leading efforts to study Kevzara in the U.S. and is in talks with the FDA, New York state Health Commissioner Howard Zucker and hospitals designated to care for Covid-19 patients and could serve as research sites for the trial, Dr. Yancopoulos said. The study would evaluate the drug only in patients with severe to critical disease.
The company, based in Tarrytown, N.Y., is likely to kick off the trial in New York, he said.
The FDA didn’t immediately respond to requests for comment. Dr. Zucker didn’t immediately respond to a request for comment.
Sanofi, based in Paris, is responsible for studying the drug in Covid-19 overseas and hopes to begin studies as soon as possible, perhaps in weeks, Dr. Patel said.
“Given the quickly evolving situation around Covid-19, we are working to leverage the knowledge of both companies in evaluating how Kevzara may be a potential treatment option for some patients,” a Sanofi spokeswoman said.
Regeneron and Sanofi co-developed Kevzara as part of a yearslong R&D collaboration. In December, the companies said that as part of a restructuring of the collaboration, Sanofi will take full ownership of the drug. But the restructuring terms aren’t final yet and could change and the companies are actively discussing how the drug’s potential treating Covid-19 may factor into the completed pact, a Sanofi spokeswoman said.
Dr. Yancopoulos said the companies jointly decided that Regeneron would lead the U.S. research program in Covid-19 “because it’s the right thing to do,” and they will figure out the details later.
Separately, Regeneron is developing new antibody drugs to kill the virus itself and aims to have the drugs ready to study in humans by the end of August, the company has said.
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